S-Space Graduate School of Public Health (보건대학원) Dept. of Public Health (보건학과) Theses (Master's Degree_보건학과)
Recognition study on the value of a vaccine clinical trial in South Korea
국내 백신 임상 시험 가치에 대한 인지도 조사
- 보건대학원 보건학과(보건학전공)
- Issue Date
- 서울대학교 대학원
- Clinical trial; Participation; Patient recognition; Patient perception; Understanding; Patient benefit
- 학위논문 (석사)-- 서울대학교 보건대학원 : 보건학과(보건학전공), 2013. 2. 조성일.
The subjects’ participation is essential in the clinical trials. However an insufficient number of studies have compared recognition of the value of clinical trials between those who have and have not participated in South Korea. The objectives of this study were to investigate differences in clinical trial recognition based on gender and to examine differences in clinical trial value recognition and future clinical trial participation between subjects who had and had not participated in a clinical trial.
To investigate the degree of recognition of the value of clinical trials in trial participants and nonparticipants in South Korea, A total of 150 participants were selected for this study. Forty-nine of 50 subjects who participated in the MTA52 study at Severance Hospital, Shinchon,(group I) completed the survey during their last visit to the study site. According to participation of MTA52 study, group I was composed of an unequal gender ratio of 17 men to 32 women. To match this gender ratio, 35 men and 65 women who had not participated in a clinical trial (group II) were recruited. All surveys were completed between September and November 2012.
Results and Discussion
In this study, we found no significant gender-based difference between groups I and II. Differences in recognition of the value of clinical trials affected trial participation. Subjects in groups I and II had notably different reasons for willingness or unwillingness to participate in a clinical trial (P < 0.0001). Group I provided positive responses, such as getting a vaccine (77.6%), receiving benefits (55.1%), participating in medical development (51.0%), and obtaining better medical services (49.0%). In contrast, group II had negative feelings about side effects (adverse events
54.0%) and fear about participating in clinical trials (39.0%). Reasons for subjects’ willingness or unwillingness to recommend clinical trial participation to family member and/or friends also differed notably between groups (P < 0.0001). Most (67.3%) subjects in group I but only 12.0% of those in group II had family members and/or friends who had participated in a clinical trial, whereas 16.0% of subjects in group I and 88.0% of those in group II did not (P < 0.0001). And the participation of family members and/or friends in clinical trials had a considerable impact on subjects’ own participation in both groups. No difference in subjects’ reported knowledge about clinical trials was observed between groups. These results suggest that not only focusing on the benefits of participating in clinical trials, but also providing education to improve individuals’ knowledge, understanding, and recognition of the safety of clinical trials are necessary. Such education would enable people to recognize the value of clinical trials and guide their decisions about whether participating in future trials could lead to the establishment of a better clinical trial environment. In addition, the sharing of government institutions’ evaluations of and opinions about clinical trials with nonparticipants would alleviate anxiety and fear by providing with credible and correct information.
Although this study has small number of subjects that limiting our ability to achieve our objectives but valuable data were nonetheless obtained.